Ajinomoto Co. v. Int'l Trade Comm'n

• Decision Date: 06 August 2019
• Docket Number: 2018-1590, 2018-1629
• Citation: 932 F.3d 1342
• Parties: AJINOMOTO CO., INC., Ajinomoto Heartland Inc., Appellants v. INTERNATIONAL TRADE COMMISSION, Appellee CJ CheilJedang Corp., CJ America, Inc., PT CheilJedang Indonesia, Intervenors CJ CheilJedang Corp., CJ America, Inc., PT CheilJedang Indonesia, Appellants v. International Trade Commission, Appellee Ajinomoto Co., Inc., Ajinomoto Heartland Inc., Intervenors
• Court: U.S. Court of Appeals — Federal Circuit

932 F.3d 1342

AJINOMOTO CO., INC., Ajinomoto Heartland Inc., Appellants

v.INTERNATIONAL TRADE COMMISSION, Appellee

CJ CheilJedang Corp., CJ America, Inc., PT CheilJedang Indonesia, Intervenors

CJ CheilJedang Corp., CJ America, Inc., PT CheilJedang Indonesia, Appellants

v.International Trade Commission, Appellee

Ajinomoto Co., Inc., Ajinomoto Heartland Inc., Intervenors

2018-1590, 2018-1629

United States Court of Appeals, Federal Circuit.

Decided: August 6, 2019

John D. Livingstone, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Atlanta, GA, argued for Ajinomoto Co., Inc., Ajinomoto Heartland Inc. Also represented by Martin David Weingarten; Charles E. Lipsey, Reston, Va; Mareesa Arnita Frederick, Cora Renae Holt, Barbara Rudolph, Washington, DC.

Houda Morad, Office of General Counsel, United States International Trade Commission, Washington, DC, argued for appellee. Also represented by Sidney A. Rosenzweig, Dominic L. Bianchi, Wayne W. Herrington.

James F. Haley, Jr., Haley Guiliano LLP, New York, NY, argued for CJ CheilJedang Corp., CJ America, Inc., PT CheilJedang Indonesia. Also represented by Steven Pepe, Ropes & Gray LLP, New York, NY; Matthew Rizzolo, Washington, DC.

Before Dyk, Moore, and Taranto, Circuit Judges.

Opinion concurring in part and dissenting in part filed by Circuit Judge Dyk.

Taranto, Circuit Judge.

Ajinomoto Co., Inc. and Ajinomoto Heartland Inc. (collectively, Ajinomoto) filed a complaint against CJ CheilJedang Corp., CJ America, Inc., and PT CheilJedang Indonesia (collectively, CJ) with the International Trade Commission, alleging that CJ was importing certain products that infringed Ajinomoto’s U.S. Patent No. 7,666,655. CJ used several strains of Escherichia coli bacteria to produce L-tryptophan products, which it then imported into the United States. The Commission determined that CJ’s earlier strains did not infringe but that CJ’s two later strains did. The Commission also found that the relevant claim of the ’655 patent is not invalid for lack of an adequate written description.

Ajinomoto appeals the Commission’s claim construction underlying the determination of no infringement by the earlier strains. CJ cross-appeals aspects of the determination of infringement by the later strains and the rejection of the invalidity challenge. We affirm.

I

A

The ’655 patent claims E. coli bacteria that have been genetically engineered to increase their production of aromatic L-amino acids, such as L-tryptophan, during fermentation, as well as methods of producing aromatic L-amino acids using such bacteria. See ’655 patent, col. 2, lines 40–45. In particular, the ’655 patent identifies a specific gene in the E. coli genome, the yddG gene, that encodes a membrane protein, the YddG protein. Id. , col. 2, lines 46–48. That protein transports aromatic L-amino acids out of the bacterial cell and into the surrounding culture medium, where they can be collected. See id. , col. 7, lines 11–16. When yddG gene activity in bacteria is enhanced so that more YddG protein is produced, the bacteria show increased production of, and increased resistance to, aromatic L-amino acids. Id. , col. 2, lines 49–57.¹

The ’655 patent describes three ways to enhance the activity of the yddG gene. First, plasmids containing additional copies of the yddG gene can be introduced into the bacterium. Id. , col. 2, lines 50–52; id. , col. 5, line 62, through col. 6, line 2. Second, additional copies of the yddG gene can be inserted into the bacterial chromosome. Id. , col. 2, lines 52–54; id. , col. 6, lines 3–6. Third, a stronger "promoter" than the one native to the E. coli yddG gene can be used. Id. , col. 2, lines 54–57; id. , col. 6, lines 12–15.²

Claim 20, the only claim of the ’655 patent still asserted when the Commission issued its decision, claims "[a] method for producing an aromatic L-amino acid, which comprises cultivating the bacterium according to any one of claims 9–12, 13, 14, 15–18, or 19." Id. , col. 24, lines 4–6 (emphasis added). Of the claims in that list, claims 9 and 15 are the independent claims, and they are the two alternatives, under claim 20, of importance in this case.

Claim 9 recites:

9. A recombinant Escherichia coli bacterium, which has the ability to accumulate aromatic L-amino acid in a medium, wherein the aromatic L-amino acid production by said bacterium is enhanced by enhancing activity of a protein in a cell of said bacterium beyond the levels observed in a wild-type of said bacterium,[1] and in which said protein consists of the amino acid sequence of SEQ ID NO: 2

[2] and said protein has the activity to make the bacterium resistant to L-phenylalanine, fluoro-phenylalanine or 5[-]fluoro-DL-tryptophan,

[3] wherein the activity of the protein is enhanced by [3a] transformation of the bacterium with a DNA encoding the protein to express the protein in the bacterium, [3b] by replacing the native promoter which precedes the DNA on the chromosome of the bacterium with a more potent promoter, [3c] or by introduction of multiple copies of the DNA encoding said protein into the chromosome of said bacterium to express the protein in said bacterium.

Id. , col. 22, lines 51–67 (paragraph breaks and bold numbering added). The Commission referred to limitation [1] as the "protein limitation," limitation [2] as the "resistance limitation," and limitation [3] as the "enhancement limitation." Claim 15 is materially identical to claim 9, except for the protein limitation. Whereas claim 9 identifies the claimed protein by a specific amino-acid sequence, claim 15 identifies it by reference to a corresponding DNA sequence—a protein "encoded by the nucleotide sequence which hybridizes with the complement of the nucleotide sequence of SEQ ID NO: 1 under" certain conditions. See id. , col. 23, lines 14–32.

B

In May 2016, Ajinomoto filed a complaint against CJ with the Commission under 19 U.S.C. § 1337. Ajinomoto alleged that CJ violated § 1337(a)(1)(B)(ii) by importing animal-feed-grade L-tryptophan products produced by a process covered by the ’655 patent.³ The Commission instituted an investigation based on Ajinomoto’s complaint.

The parties before us, including the Commission, agree that whether the accused products were produced by a process covered by the patent is a question of infringement. The proceeding focused on three groups of E. coli strains that CJ has used to produce tryptophan. First, CJ’s "earlier strains" contained both the native E. coli yddG gene and the native E. coli yddG promoter, except that the first nucleotide of the promoter was changed through chemical mutagenesis, resulting in a stronger promoter. Second, in November 2016, several months after Ajinomoto filed its complaint, CJ began using its first "later strain," which contained two copies of a yddG gene: (1) the native E. coli yddG gene with the native E. coli yddG promoter; and (2) a non-E. coli yddG gene with two promoters—(2a) a native non-E. coli yddG promoter and (2b) an rmf promoter.⁴ Third, in December 2016, CJ started using its second "later strain," which also contained two copies of a yddG gene: (1) the native E. coli yddG gene with the native E. coli yddG promoter; and (2) a codon-randomized non-E. coli yddG gene with two promoters—(2a) an rmf promoter and (2b) an rhtB promoter.⁵

In August 2017, the administrative law judge (ALJ) issued a final initial determination. The ALJ construed "replacing the native promoter ... with a more potent promoter" in the enhancement limitation to mean "removing the native upstream region of the yddG gene and inserting one of a class of promoters that controls expression of a different gene." J.A. 90–91. Using that construction, the ALJ found that CJ’s earlier strains did not infringe; he found that they failed to meet the enhancement limitation because CJ created the more potent promoter in those strains by mutagenesis of a single nucleotide rather than removal of the entire native promoter and insertion of a new promoter. As to CJ’s later strains, the ALJ found that (a) the first later strain did not infringe because Ajinomoto had failed to prove that it met the resistance limitation, and (b) the second later strain also did not infringe because its non-E. coli YddG protein was not equivalent to the claimed E. coli YddG protein under the doctrine of equivalents. Finally, the ALJ found that claim 20 of the ’655 patent is invalid for lack of an adequate written description of the "more potent promoter" limitation incorporated into that claim.

In October 2017, the full Commission decided to review the ALJ’s final initial determination in its entirety, and in December 2017, the Commission issued its decision. It affirmed the ALJ’s construction of "replacing the native promoter ... with a more potent promoter" and accordingly affirmed the ALJ’s finding that CJ’s earlier strains did not infringe. But the Commission reversed several of the ALJ’s other findings. Specifically, it determined that both of CJ’s later strains met all disputed claim limitations and thus infringed claim 20 and that claim 20 was not proved to lack an adequate written description. The Commission accordingly entered a limited exclusion order against CJ’s infringing products, i.e. , those made by both of CJ’s later strains but not its earlier strains. The Commission also issued a cease-and-desist order against CJ America, which held inventory of the infringing products.

Ajinomoto and CJ both timely appealed. We have jurisdiction under 28 U.S.C. § 1295(a)(6).

II

We begin with Ajinomoto’s appeal of the Commission’s finding of no infringement by the earlier strains. Ajinomoto challenges that finding solely by arguing that the Commission erred in its claim construction of "replacing the native promoter ... with a more potent promoter." Ajinomoto argues that, properly construed, the phrase is not limited to removing the entire native promoter and inserting a new promoter, as the Commission concluded, but encompasses mutagenesis of individual...